Investigation Lead, Manufacturing Deviations

Biopharma Careers; Dublin; On-site; EUR 72,000 - 97,000; Full time

Job summary

Amgen Dun Laoghaire in Ireland is seeking a Manufacturing Specialist (Investigation Lead) to manage deviations for fill/finish, inspection and packaging. You will lead cross-functional teams, perform root cause analyses, develop CAPAs, and document findings with precise technical writing.

You will drive continuous improvements to the investigation process, prepare clear reports for regulators and internal auditors, and communicate progress to leadership while navigating ambiguity with structured

Qualifications

• Bachelor's/Assoc degree with 5+–10+ years biotech/pharma manufacturing or manufacturing support experience.
• Detailed technical understanding of fill/finish operations.
• Experience with compliance, problem-solving and quality systems.

Responsibilities

• Lead deviation investigations for fill/finish, inspection and packaging.
• Establish investigation teams, drive root cause analysis and develop CAPAs.
• Produce compliant documentation and clear technical write-ups.
• Present investigations to regulators and internal auditors.
• Coordinate cross-functional teams and manage end-to-end projects.

Education

Bachelor's in Science/Engineering

Associate's in Science/Engineering

Job description

Amgen Dun Laoghaire in Ireland is seeking a Manufacturing Specialist (Investigation Lead) to manage deviations for fill/finish, inspection and packaging. You will lead cross-functional teams, perform root cause analyses, develop CAPAs, and document findings with precise technical writing.

You will drive continuous improvements to the investigation process, prepare clear reports for regulators and internal auditors, and communicate progress to leadership while navigating ambiguity with structured